On March 15, 2023 Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class therapies targeting the Hippo pathway, reported that the first clinical data for a cancer treatment targeting the Hippo pathway will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 (Press release, Vivace Therapeutics, MAR 15, 2023, View Source [SID1234628846]). Results from the company’s Phase 1 clinical study of its first-in-class transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor, VT3989, will be presented by Timothy A. Yap, Ph.D., of the University of Texas, M.D. Anderson Cancer Center, during an oral plenary session at the conference. The AACR (Free AACR Whitepaper) conference is being held April 14-19, 2023, in Orange, Florida.

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The Phase 1 study (View Source) is a multi-center, open label trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and biological activity of VT3989 in patients with refractory metastatic solid tumors, including refractory pleural malignant mesothelioma. The study included both a dose escalation and a dose expansion phase, the latter of which also enrolled patients with neurofibromatosis 2 (NF2) mutant tumors.

Details of the oral presentation at the AACR (Free AACR Whitepaper) conference are as follows:

Presentation #CT006:

Title: First-in-Class, First-in-Human Phase 1 Trial of VT3989, an inhibitor of Yes-Associated Protein (YAP)/Transcriptional Enhancer Activator Domain (TEAD), in Patients (pts) with Advanced Solid Tumors Enriched for Malignant Mesothelioma and Other Tumors with Neurofibromatosis 2 (NF2) Mutations

Presenting Author: Timothy A. Yap, Ph.D., University of Texas, M.D. Anderson Cancer Center

Session: CTPL02: Hope for Rare Cancers: Novel Targeted and Immunotherapy Agents

Date/Time: Sunday, April 16, 2023, 3:30 – 3:45 p.m. Eastern

Location: W Hall A2-3
Vivace’s proprietary compounds, including lead development candidate VT3989, inhibit palmitoylation of members of the TEAD protein family, including both covalent and non-covalent inhibitors. Pre-clinical research and development activities have demonstrated that VT3989 is active as a monotherapy against tumors that rely upon dysfunction of the Hippo pathway, and in combination with other anti-cancer therapies in additional tumor types.

On March 15, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that it will host a conference call and live webcast on Tuesday, March 28, 2023 at 8:30 am EDT (5:30 am PDT) to report fourth quarter and full-year 2022 financial results and provide recent corporate updates (Press release, Aadi Bioscience, MAR 15, 2023, View Source [SID1234628845]).

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Conference Call Information

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance here: Conference Registration (vevent.com). Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the website for at least 30 days.

On March 15, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that the Company will be presenting preclinical and clinical data on its lead asset TAC01-HER2 for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Orlando, April 14-19 (Press release, Triumvira Immunologics, MAR 15, 2023, View Source [SID1234628844]). The presentations will include updated clinical data and product characterization from the ongoing Phase I/II trial of autologous TAC01-HER2 (NCT04727151) in patients with solid tumors and preclinical data on an allogeneic HER2-TAC T cell product.

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"We are pleased to present additional validation of our lead clinical program TAC01-HER2, currently in Phase I/II trials, supporting the efficiency of our proprietary Cocoon platform to manufacture potent autologous TAC01-HER2 cells using leukocytes from cancer patients," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "Interim results will also be presented from our ongoing Phase I/II trial investigating the safety and efficacy of autologous TAC01-HER2 in HER2+ refractory solid tumors demonstrating a favorable safety profile and promising clinical activity as evident by reduction of measurable disease and prevention of fast cancer progression in the majority of patients enrolled in the Phase I trial. Further, we will present new preclinical data from our allogeneic T cell-based products in development demonstrating their potential to avoid graft versus host disease."

Presentation Details:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors
Authors: Ecaterina E. Dumbrava, MD, Daniel Olson, MD, Samuel Saibil, MD, Brooke Pieke, Mridula A. George, MD, Riemke Bouvier, Kelly Gruber, Kara Moss, Nathan Ternus, Maria Apostolopoulou, Deyaa Adib, MD, and Benjamin L. Schlechter, MD.
Session: Phase II Clinical Trial 2
Date and Time: Tuesday, April 18, 2023, from 9 a.m. to 12:30 p.m. EDT
Abstract Number: CT234

Title: Patient-derived TAC01-HER2 TAC T cells produced in Cocoon Platform are highly functional in models of solid tumors
Authors: Ling Wang, Stacey X. Xu, Tania Benatar, Ritu R. Randhawa, Philbert Ip, Prabha Lal, Thanyashanthi Nitya-Nootan, Laura Shaver, Heather MacGregor, Suzy Prosser, Sadhak Sengupta, Christopher W. Helsen, and Andreas G. Bader
Session: Adoptive Cell Therapy 2
Date and Time: Monday, April 17, 2023, from 1:30 p.m. to 5 p.m. EDT
Abstract Number: 3188

Title: Preclinical characterization of allogeneic Vγ9Vδ2 HER2-TAC T cells for the treatment of HER2-positive solid tumors
Authors: Suzanna L. Prosser, Stacey X. Xu, Ling Wang, Ritu R. Randhawa, Sailaja Pirati, Laura Ravensbergen, Seungmi Yoo, Miyoung Jung, Laurentia Gheorghiu, Angel Gomez, Gurleen Sandhu, Chris Ayers, Donna Rill, Christopher W. Helsen, Andreas G. Bader.
Session: CAR T-cell Therapy 1
Date and Time: Monday, April 17, 2023, from 9 a.m. to 12:30 p.m. EDT
Abstract Number: 1773

Abstracts are currently available on the AACR (Free AACR Whitepaper) website. A copy of the presentations will also be available after the closure of the meeting on April 19, under the Presentations & Publications tab of the News & Resources section of the Company’s website.

On March 15, 2023 OnQuality Pharmaceuticals ("OnQuality"), a targeted oncology supportive therapy company developing innovative medications to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced side effects occurring in the skin and gastrointestinal tract) and to improve the quality of life for patients receiving anticancer medications, reported it will present preclinical data for its two drug candidates, OQL025 and OQL06x, at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (Press release, OnQuality Pharmaceuticals, MAR 15, 2023, View Source [SID1234628843]). The conference will be held in Orlando, FL, April 14-19, 2023.

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EGFR inhibitors are a class of drugs commonly used in the treatment of various cancers, including lung and colorectal. However, EGFR inhibitors can lead to dose-limiting skin toxicities and/or diarrhea in some patients.

The most common skin toxicity associated with EGFR inhibitors is acneiform rash, which frequently appears on the face, neck, upper chest, and back. The incidence ranges from 20% to over 90% among patients receiving these drugs.

The incidence of EGFR inhibitor-induced diarrhea ranges from 40% to 90% depending on the specific agent and dose. The severity of diarrhea can also vary, with some patients experiencing moderate or severe diarrhea that can lead to dehydration, electrolyte imbalance, and other serious complications. Cancer patients experiencing diarrhea have a 40% higher therapy discontinuation rate compared to those who do not.

To address this significant unmet need, OnQuality is developing OQL025 and OQL06x. OQL025 is a novel topical cream, and OQL06x a gut-restricted JAK inhibitor.

"OQL025 and OQL06x are first-in-disease drug candidates for EGFR inhibitor-induced skin rash and diarrhea." said Robert C. Tyler, Ph.D., Senior Medical Director of OnQuality. "I am looking forward to sharing the data at the conference."

Abstract Information:

Title: OQL025, a topical cream for the prevention of epidermal growth factor receptor inhibitor-induced skin rash
Presented By: Robert C. Tyler, Ph.D.
Session Category: Clinical Research Excluding Trials
Session Title: Cancer Outcomes 1
Session Date and Time: Monday Apr 17, 2023 1:30 PM – 5:00 PM
Abstract Number: 3211

Title: OQL06x, a gut-restricted janus kinase inhibitor to control epidermal growth factor receptor inhibitor-induced diarrhea
Presented By: Robert C. Tyler, Ph.D.
Session Category: Clinical Research Excluding Trials
Session Title: Cancer Outcomes 1
Session Date and Time: Monday Apr 17, 2023 1:30 PM – 5:00 PM
Abstract Number: 3212

On March 15, 2023 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for cancer, fibrosis and inflammation, reported that it is presenting a poster on its preclinical drug candidate BBT-207 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 annual meeting taking place on April 14-19 in Orlando, Florida (Press release, Bridge Biotherapeutics, MAR 15, 2023, View Source [SID1234628842]).

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The following abstract is now available on AACR (Free AACR Whitepaper)’s website.

Presentation Title: BBT-207 is a broad-spectrum, highly potent, 4th generation EGFR TKI with enhanced activity to both sensitizing and treatment-emergent EGFR mutations including T790M and C797S

Session Category: Experimental and Molecular Therapeutics

Session Title: Tyrosine Kinase and Phosphatase Inhibitors 1

Session Date & Time: Tuesday, April 18, 2023, 9:00 a.m. — 12:30 p.m.

Abstract Number: 4018

BBT-207, which is currently under IND-enabling preclinical development, is an internally discovered fourth-generation EGFR TKI (Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor) with potent preclinical activity against a broad range of EGFR mutations including C797S in non-small cell lung cancer (NSCLC). The preclinical activity profile of BBT-207 allows it to be positioned in earlier-line settings for first, second and third generation EGFR TKI resistant patients, with the potential to treat or prevent brain metastases.

During last year’s AACR (Free AACR Whitepaper) poster presentation, the company presented preclinical data showing the potent anti-tumor efficacy of BBT-207, observed through both in vitro and in vivo studies. This year, the company will discuss the anti-tumor efficacy in tumor models with a broad range of EGFR mutations. Further, the poster will provide updated in vivo data on brain metastasis inhibition.

"Following last year’s AACR (Free AACR Whitepaper) poster presentation, we are excited to showcase the most current data from newly conducted preclinical efficacy studies, which showed extended survival rates in NSCLC models with EGFR mutations," said Jimmy Jin. M.D., Ph.D., Bridge Biotherapeutics Head of Discovery Biology. "We believe BBT-207 has the potential to be a broad-spectrum fourth-generation EGFR TKI, with the capacity to further augment treatment through combinations."

Bridge Biotherapeutics plans to initiate the Phase 1 clinical study of BBT-207, focusing on the treatment of advanced non-small cell lung cancer patients, in the first half of the year.